Apparatus and method to reduce the likelihood of wrong site surgery

ABSTRACT

The invention is an apparatus comprising a garment that prevents wrong site surgery. The garment comprises a garment portion, a warning, a patient information indicator, and a verification. The warning, patient information indicator and verification can be integral with the garment portion or printed on a separable medium. The method of the present invention comprises steps to prevent wrong site surgery including placing a garment on a non-operative body part, placing a warning on said garment, placing patient information on said garment, and requiring the patient or an authorized individual to verify that the patient is willingly undergoing the surgery. The above pieces of information can be removed from the garment and placed in the patient&#39;s medical record.

CLAIM OF PRIORITY

This application claims the benefit of U.S. provisional Application No. 60/545,667 filed Feb. 19, 2004.

FIELD OF THE INVENTION

The invention is an apparatus and method designed to reduce the likelihood of wrong site surgery. One example of an operation being performed on a wrong body part occurs when, in the instance where there is an identical body part on either side of the body, an operation is performed on the incorrect side. The most obvious example is in the case of surgery that is performed on an extremity (arm or leg).

BACKGROUND OF THE INVENTION

Wrong site surgery (WSS) is defined as: a) the wrong operation performed on a patient, b) an operation performed on the wrong patient or c) an operation performed on the wrong body part. Wrong site surgery is characterized as a preventable medical error and thus great efforts are being made to reduce the incidence of WSS.

Current methodologies to prevent WSS include the use of indelible markers and adhesive labels to identify appropriate surgical sites. These methodologies have inherent deficiencies and wrong site surgery continues to occur. A zero-tolerance policy for wrong site surgery has been mandated by major agencies and professional organizations that accredit health care providers. Therefore, a need exists for better methods to further reduce the likelihood of wrong site surgery.

SUMMARY OF THE INVENTION

In one embodiment, the apparatus comprises a garment portion. The garment portion can be a sleeve, a partial sleeve or gown that is placed on a patient or worn by a patient during an operation. The garment portion is constructed from any material that would be suitable to come in contact with human tissue and would meet the operating room safety criteria. For example, the garment portion would be preferably made of a hypoallergenic and fire proof material. The sleeve embodiment of the garment is designed to be placed on and cover an entire extremity such as an arm or a leg. The partial sleeve embodiment of the garment is designed to be placed on and cover only a portion of an extremity such as a shoulder, elbow or wrist on the arm or a hip, knee or ankle on the leg.

In the instance where a surgeon is to perform an operation on a body part of which there are two, one on either side of the body, the garment is placed on the non-operative body part (“the non-operative body part”). An example is surgery to be performed on an extremity such as an arm or a leg. The presence of the garment on the non-operative side will prevent the creation of a sterile surgical field, and thus a wrong site surgery, on that part of the body.

The garment has several components that serve to collect, record, and convey important information regarding the surgery. A patient information indicator correctly identifies the patient name, surgery to be performed including the correct side, and the operating surgeon. A verification component confirms that the patient was an active participant in placing the garment on the non-operative body part. Said components can comprise data that is recorded on paper or other media suitable for printed information. In another embodiment, this information is recorded on material that has been integrated into the structure of the garment portion. Alternatively, the information may be recorded on paper or other media that is not integral to the garment. In this embodiment, the patient information indicator and the verification is recorded on separate material and then displayed by placing it into an information display means. In one embodiment, this display component is preferably a “pocket” with a transparent face that allows the information to be viewed by all who come into contact with the patient. The display means is placed on a visible area of the garment portion. The patient information indicator and the verification may be recorded on a suitable media, such as paper, that can be removed from the display means and then incorporated into the patient medical record.

Another feature of the garment communicates a warning, i.e., a message that the body part on which the garment is placed is not a surgical site and that the garment is to be removed only in the case of an emergency. The exact wording of this warning is discretionary and may be determined by medical staff, medical professionals or other personnel performing the surgery. One embodiment would result in the message being printed directly on the material that comprises the garment. Alternatively, the warning can be displayed in a display means as described above.

In another embodiment, a step of the inventive method is to place the garment on the side of the body on which surgery is not to be performed (“non-operative side”) or the non-operative body part. Patient information is also provided. Such information could preferably include the patient's name, the surgery to be performed including the correct side of the body, the surgeon who will be performing the operation as well as any additional information that may be necessary for patient safety. As described above, this information is recorded either on material integral to the garment or recorded on material that can be secured to the garment, for example, on paper that is inserted into a display means. Another step in the method is the verification step in which the patient or authorized individual verifies through a process such as a signature or an equivalent, that the patient is an active participant in the placement step and/or the patient identification step. In some embodiments, a witness may be required to verify the placement of the garment as well as the completion of the patient identification and/or verification steps. Preferably, copies of the patient information indicator and verification are made available for the health care provider.

In this way, the garment portion is visible to those involved with the surgery. The part of the body that is not scheduled for surgery is covered with the garment. As an example, if the operating surgeon mistakenly approaches the wrong body part to begin to prepare for the surgery he/she will encounter the garment. The presence of the garment will prevent the surgeon from preparing the body part for surgery. One of the invention's features will clearly inform the surgeon of the intent of the garment with a message such as “THIS IS NOT A SURGICAL SITE. REMOVE ONLY IN THE CASE OF AN EMERGENCY.” The surgeon can confirm all the important patient identification information from the area of the garment designed to display said information. An embodiment of the garment and method allows for the surgeon to confirm, by means of a signature or an equivalent, that he/she reviewed the important patient identification information prior to the start of the surgery.

One embodiment of the method allows for a copy of the patient identification and verification data to be removed from the garment at the end of the case and be incorporated into the patient medical record.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1A shows the full sleeve embodiment on a patient's left arm.

FIG. 1B shows the full sleeve embodiment on a patient's left arm with openings and cut-outs shown.

FIG. 1C shows the partial sleeve embodiments for the shoulder, elbow, and hand/wrist.

FIG. 2A shows the full sleeve embodiment on a patient's left leg.

FIG. 2B shows the partial sleeve embodiments on the hip, knee, and foot of a patient.

FIG. 3A is a view of the partial sleeve embodiment for the shoulder.

FIG. 3B is an alternative view of the partial sleeve embodiment for the shoulder looking into the first opening.

FIGS. 4A and 4B show the partial sleeve embodiment for the elbow.

FIGS. 5A and 5B show partial sleeve embodiments for the hand/wrist.

FIGS. 6A and 6B show the partial sleeve embodiments for the foot.

FIGS. 7A and 7B show the display means, which can be incorporated into the embodiments described herein.

FIG. 7C shows an embodiment where in the display means is used with the garment.

DESCRIPTION OF THE PREFERRED EMBODIMENT

FIG. 1 illustrates an embodiment of the invention wherein the garment 100 is a full sleeve to be used with an arm. As used herein the term “sleeve” will enjoy its ordinary and accustomed meaning. Though not limited by the following definition, “sleeve” can mean an open-ended flat or tubular covering able to be placed over an extremity. Appropriately sized, the sleeve can accommodate any body extremity including an arm, a leg, a hand, a foot, individual or combinations of fingers and toes. The sleeve could be made form-fitting by being comprised of an elastic or stretch material. The skilled artisan will appreciate that the above list is not exhaustive and that the sleeve could be used with any extremity. Note that the garment portion may comprise a wrap, i.e., a flat piece of material that is able to be wrapped around an extremity and secured thereon by means of securing elements at the ends of said piece of material. For example, the wrap could be wrapped around an extremity and secured by securing elements, which are on the ends of the wrap, the male portion of the element on a first end and a first surface of the wrap and a female version of the element on a second end and second surface of the wrap. In the above embodiment, the securing element could be Velcro® or snaps. In another embodiment the securing element could be band-like fabric strips functioning as ties as is commonly used on conventional hospital gowns. Once secured, the wrap would function similar to a sleeve, although a sleeve configuration is the preferable one since it can be slid on and off without the step of securing. The sleeve embodiment is also preferable because it has been found that a sleeve is able to stay on an extremity better than the aforementioned stickers, and better than material that is simply strapped on to or around the extremity.

FIG. 1 shows the garment 100 on the left arm of a human body. As with all figures herein, the body is shown in phantom. When the garment 100 is used on the arm, it is as a sleeve. The full sleeve embodiment of the garment 100 comprises a garment portion 20. The garment portion 20 covers the arm 30 from shoulder 40 to hand 50 thus preventing a wrong site surgery. Referring to FIG. 11B, the arm 30 is inserted into a first opening 16 in the garment portion 20 and the hand 50 exits at a second opening 18 so that the entire extremity is covered. The garment portion 20 comprises a warning 60 that, in the preferred embodiment, informs individuals, including medical staff and professionals, that no surgery is to be performed on the body part covered by the garment 100 and that the garment 100 should only be removed in the case of an emergency. Preferably, this warning 60 is printed directly on the garment portion 20. The garment portion 20 also comprises a patient information indicator 70, which preferably comprises the name of the patient, the surgery to be performed (including the correct location of the surgery), and the name of the operating surgeon. The patent information indicator 70 also comprises a verification 75, which can include any verification information such as the patient's signature verifying that he or she was an active participant in placing the garment 100. The verification 75 is represented as a signature line through the figures. In one embodiment of the method the warning 60, patient information indicator 70, and verification 75 are recorded on material that is integral to the garment portion 20. In another embodiment of the garment this information is recorded on separate material and then placed in a display means, which will be discussed in more detail with reference to FIGS. 7A-7C below. The skilled artisan will appreciate that the warning 60, patient information indicator 70 and verification 75 can be placed at any location on the garment. Preferably, the patient information indicator 70 comprises the verification 75.

Also shown in FIG. 1B is an opening 172, which allows access to the underlying body part, which in this figure is an arm 30. Access may be necessary, for example, for administration of intravenous solutions, medicine, or food. The opening 172 can exist on any of the embodiments herein and can be located anywhere that will appropriately provide access as described above. Some embodiments may have more than one opening. The opening 172 can be of any size or shape.

Other embodiments of the garment involve the use of partial sleeves rather than full sleeves as shown in FIG. 1C. The partial sleeve embodiments 200, 300, 400 for the shoulder 40, elbow 310 and wrist/hand 50 are shown. As with the full sleeve embodiment shown in FIGS. 1A and 1B, each partial sleeve 200, 300, 400 comprises a garment portion 20 that is designed to cover a part of the body and prevent wrong site surgery. As with the full sleeve embodiment, the partial sleeve embodiments 200, 300, 400 each comprise a warning 60 preferably indicating that no surgery is to be performed on the body part on which the garment is placed as well as that the garment is to be removed only in the case of an emergency. In addition, as in the case of the full sleeve embodiment, the partial sleeve embodiments 200, 300, 400 comprise the patient information indicator 70. Also as in the full sleeve embodiment, the patient information indicator 70 can comprise a verification 75. Also similar to that which is described above, the warning 60, patient information indicator 70, and verification 75 can be placed on material that is integral to the garment or on material that is separate from the garment which is then secured to said garment portion 20. The warning 60, patient information indicator 70 or verification 75 can be placed at any location on the garment.

FIGS. 2A and 2B illustrate the full sleeve and the partial sleeve embodiments of the garment on a lower extremity. The Figures represent the left leg 65 and the left hip 34 viewed from the front. The structure of the embodiments in FIGS. 2A and 2B is essentially the same as the above-described embodiments. But for clarity, some of the structure of the embodiments in FIGS. 2A and 2B will be discussed in detail below.

The full sleeve embodiment of the garment 500 on a lower extremity comprise a garment portion 20 that covers the leg 65 from hip 34 to foot 36 thus preventing a wrong site surgery. The leg 65 is inserted into a first opening 501, and the foot 36 exits at a second opening 502 so that the entire extremity is covered. The garment portion 20 comprises a warning 60 that preferably indicates that no surgery is to be performed on the body part covered by the garment 500 and that the garment 500 should only be removed in the case of an emergency. The garment portion 20 also comprises a patient information indicator 70, which comprises information such as the name of the patient, the surgery to be performed including the correct location and the name of the operating surgeon. The patient information indicator 70 preferably also comprises verification 75 information such as the patient's signature verifying that he or she was an active participant in placing the garment 500.

FIG. 2B shows partial sleeves on the lower extremity. The partial sleeve embodiments 125, 225, 325 for the hip 34, knee 35 and foot 36 are shown. The structure of the partial sleeve embodiments shown in FIG. 2B is essentially the same as the above partial sleeve embodiments, except that garments 125, 225 and 325 are used with the hip 34, knee 35 and foot respectively. Therefore, reference should be had to the discussion above, and in particular, to the discussion with reference to FIG. 1C with the understanding that the body parts to which the 125, 225, 325 apply are different than in FIG. 1C.

FIGS. 3A and 3B further illustrate the garment 200 used with a shoulder 40. All elements as described herein are present in this embodiment. A first opening 16 and second opening 18 are shown, which allow the upper arm and shoulder 40 to pass through. FIG. 3A shows that the arm is placed into the garment though the first opening 16 and exits through the second opening 18 so that the garment 200 rests on the shoulder 40. First 17 and second 19 ends are shown. FIG. 3B shows a side view of the garment 200 as it would appear to a patient preparing to place it on. The first opening 16 for placing the arm through is viewed face on. The second opening 18 through which the arm exits the garment 200 is seen at the lower end of the garment 200. In one embodiment, elastic material is secured to the ends 17, 19 which is represented by the bunched appearance of the ends in FIG. 3A.

FIG. 4A shows a side view of the partial sleeve embodiment 300 for an elbow. FIG. 4B shows a face on view of the garment 300 (from first opening 16 to second opening 18), i.e., looking into the long axis from first opening 16 through to the second opening 18. Refer to the discussion above, specifically with reference to FIG. 1C, for a description of the garment on the elbow 310. FIG. 4A shows that the arm is placed into the garment 300 through a first opening 16 and exists through a second opening 18 so that the garment rests on the elbow (not shown in FIG. 4A).

FIGS. 5A and 5B illustrate a top view and a side view respectively, of the partial sleeve embodiment for the hand and wrist 50. Refer to the discussion above, and specifically to the discussion in FIG. 1C, for a description of the elements of the garment 400 on the wrist. FIG. 5A shows that the hand 50 is placed into the garment though a first opening 16. The fingers 411 then exit through a plurality of openings, one of which is shown as 412, so that the garment 400 rests on the wrist and hand 50. As with most above embodiments, it will be seen that the warning 60, patient information indicator 70, and verification 75 are present. Note that they are partially viewable in FIG. 5B due to the perspective of the figure.

FIG. 6A illustrates a side view of an embodiment of the garment 325 on a foot 36. FIG. 6A shows that the foot 36 is placed into the garment 325 though a first opening 16. The foot 36 then exits through a second opening 18 so that the garment rests on the ankle 33 and foot 36. Note also a third opening 18A for the heel to exit. Refer to the discussion above for a description of elements of the garment 325, e.g., warning 60, patient information indicator 70, and verification 75.

FIGS. 7A, 7B and 7C illustrate the display means 134 of the garment that may be used to display the important patient information 70, warning 60, and/or verification 75. The display means 134 is designed to be affixed to the garment portion 20 of the garment by means of sewing Velcro® adhesive or any other convention means. As shown in FIGS. 7A and 7B, the patient information indicator 70, and verification 75 are recorded on paper or any similar material and placed into the display means 134 so that it may be viewed by any person involved in the surgical procedure. The display means 134 will be used when the paper or suitable media is itself not integral to the garment. The display means 134 comprises a transparent face 135 so that the patient information indicator 70 and the verification 75 can be visualized (or in some embodiments, warning 60). On one side of the component 134 is an opening 136 that will allow the patient information indicator 70 and verification 75 to be placed into the means 134. In FIG. 7A, the patient information indicator 70 is partially removed from the means 134. FIG. 7C shows the display means 134 on a full sleeve embodiment of invention on the leg. Note that the display means 134 can be used in conjunction with any embodiment described herein.

While the invention has been illustrated and described in detail in the drawings and the foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiment has been shown and described and that all changes, equivalents, and modifications that come within the spirit of the invention defined by the following claims, are desired to be protected. 

1. A garment to assist in the prevention of wrong site surgery, said garment comprising: a. a garment portion to be placed on a body part of a patient on which surgery is not to be performed; b. a warning on said garment portion, said warning comprising information indicating that surgery is not to be performed on said body part; and c. a patent information indicator.
 2. A garment to assist in the prevention of wrong site surgery, said garment comprising: a. a garment portion to be placed on a body part of a patient on which surgery is not to be performed; b. at least one display means having a transparent face and secured to said garment portion, said display means having at least one opening; c. a warning dimensioned to fit inside of said at least one display means, said warning comprising information indicating that surgery is not to be performed on said body part, and d. patent information indicator dimensioned to fit inside of another of said at least one display means, wherein said patient information indicator and said warning able to be removed from said display means and placed in said display means.
 3. A garment as claimed in claim 1 further comprising a verification.
 4. A garment as claimed in claim 2 further comprising a verification.
 5. A garment as claimed in claim 1 wherein said patient information indicator comprises information of an appropriate surgical sight.
 6. A garment as claimed in claim 2 wherein said patient information indicator comprises information of an appropriate surgical sight.
 7. A garment as claimed in claim 1 wherein said patient information indicator comprises said patient's name.
 8. A garment as claimed in claim 2 wherein said patient information indicator comprises said patient's name.
 9. A garment as claimed in claim 1 wherein said patient information indicator comprises a surgeon's name.
 10. A garment as claimed in claim 2 wherein said patient information indicator comprises a surgeon's name.
 11. A method to prevent wrong site surgery comprising the steps of: a. placing a garment on a body part on which surgery is not to be performed; b. placing a warning on said garment, said warning comprising information that surgery is not to be performed on said body part; c. placing patient information indicator on said garment.
 12. The method of claim 10 further comprising the step of requiring said patient to verify that said patient is willingly participanting in said surgery thereby creating a verification.
 13. The method of claim 10 further comprising the step of requiring an authorized individual to verify that the patient is willingly participating in said surgery thereby creating a verification.
 14. The method of claim 10 further comprising the steps of: a. removing said patient indicator from said garment; and b. placing said patient information indicator in a medical record of said patient.
 15. The method of claims 11 or 12 further comprising the steps of: a. removing said verification from said garment; and b. placing said verification in a medical record of said patient.
 16. The method of claim 10 wherein said verification comprises a signature.
 17. The method of claim 11 wherein said verification comprises a signature.
 18. The garment of claim 1 wherein said garment portion is a sleeve.
 19. The garment of claim 2 wherein said garment portion is a sleeve.
 20. The garment of claim 1 wherein said garment portion is a wrap having two ends with a securing means on each end.
 21. The garment of claim 2 wherein said garment portion is a wrap having two ends with a securing means on each end. 